Investigating immunoglobulin types in autoimmune diseases with high antibody levels
The Distribution of Immunoglobulin Isotype in Polyclonal Hypergammaglobulinemia in Systemic and Autoimmune Diseases
This study is trying to see if the types of antibodies in people with certain autoimmune diseases can help predict the risk of developing conditions like lymphoma or monoclonal gammopathy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06054373 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the distribution of immunoglobulin isotypes in patients suffering from polyclonal hypergammaglobulinemia associated with autoimmune diseases. It will focus on conditions such as systemic lupus erythematosus, rheumatoid arthritis, and Sjögren's syndrome, among others. The study seeks to determine whether the distribution of these isotypes can serve as a predictor for conditions like lymphoma or monoclonal gammopathy. By analyzing the immunoglobulin profiles, the researchers hope to gain insights into the disease-specific characteristics of polyclonal hypergammaglobulinemia.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, or Sjögren's syndrome.
Not a fit: Patients under 18 or those with chronic viral hepatitis, HIV, syphilis, or tuberculosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of autoimmune diseases and improve predictive measures for serious complications like lymphoma.
How similar studies have performed: While the specific approach of analyzing immunoglobulin isotypes in this context may be novel, related studies have shown the importance of immunoglobulin profiles in understanding autoimmune diseases.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * All adult patients \> 18 years old * patients with one of the following diseases: systemic lupus erythematosus, rheumatoid arthritis, Sjögren's syndrome, autoimmune hepatitis, sarcoidosis or lymphoma. Exclusion Criteria: * Age \< 18 years; * chronic viral hepatitis; * HIV infection, syphilis, * tuberculosis
Where this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Valéry Salle, MD
- Email: salle.valery@chu-amiens.fr
- Phone: 03 22 66 82 30
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.